MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM; BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM

Model Number	H7493926032400
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.(b)(4).
Event or Problem Description
It was reported that stent dislodgement occurred.The target lesion was located in the right coronary artery.A 4.00 x 32mm synergy ii drug-eluting stent was advanced but failed to cross the lesion.However, accordioned on the end of the non-bsc guide and when the device was removed from the sheath, it was noted that the stent came off the balloon.The entire system was removed from the patient and the procedure was completed with another 4.00 x 32mm synergy stent.No patient complications were reported and the patient's status was fine.
Additional Manufacturer Narrative
Device evaluated by mfr., eval summary attached, method codes, result codes, conclusion codes updated.Device evaluated by mfr: a synergy ii us mr 4.00 x 32mm was returned for analysis.The stent delivery system (sds) was not returned for analysis therefore individual assessment of the catheter could not be performed.The stent was returned detached from the sds and was severely stretched and damaged.No other issues were identified during the product analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is caused by other device as another device/drug/subsequent procedure caused the complaint event.(b)(4).
Event or Problem Description
It was reported that stent dislodgement occurred.The target lesion was located in the right coronary artery.A 4.00 x 32mm synergy ii drug-eluting stent was advanced but failed to cross the lesion.However, accordioned on the end of the non-bsc guide and when the device was removed from the sheath, it was noted that the stent came off the balloon.The entire system was removed from the patient and the procedure was completed with another 4.00 x 32mm synergy stent.No patient complications were reported and the patient's status was fine.

• Brand Name: SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
• Common Device Name: BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7664243
• Report Number: 2134265-2018-05935
• Device Sequence Number: 19421888
• Product Code: NIQ
• UDI-Device Identifier: 08714729840374
• UDI-Public: 08714729840374
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/25/2018
• Device Model Number: H7493926032400
• Device Catalogue Number: 39260-3240
• Device Lot Number: 21322639
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2018
• Initial Date Received by Manufacturer: 06/13/2018
• Supplement Date Received by Manufacturer: 07/17/2018
• Initial Report FDA Received Date: 07/05/2018
• Supplement Report FDA Received Date: 08/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 89 YR